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Ovarian CancerPhase 1NCT05636111

Phase 1b of Lurbinectedin in Combination With Weekly Paclitaxel and Bevacizumab in Platinum-resistant Ovarian Cancer

A Phase 1 study testing Paclitaxel, Bevacizumab and Lurbinectedin in people with Ovarian Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

To learn if adding lurbinectedin to the combination of paclitaxel and bevacizumab can help to control advanced cancer. Read more about this study

Who is it for?
Ages 18 years and older, women only
Conditions the study is for
Ovarian Cancer
What is being tested?
Paclitaxel, Bevacizumab and Lurbinectedin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
34 participants
Where
1 siteUnited States
Study dates
12 Jul 2023to 31 Dec 2026
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Inclusion criteria will be assessed within 28 days of starting study treatment:
  • Ability to provide signed informed consent in accordance with federal, local, and institutional guidelines.
  • Age ≥ 18 years at time of study entry
  • Willing and able to comply with the protocol for the duration of the study including undergoing treatment and scheduled visits and examinations including follow up.
  • Histologically confirmed and documented ovarian, fallopian tube or peritoneal carcinoma: Patients with platinum refractory* or platinum resistant** disease are allowed. Prior anti-VEGF targeted therapy (e.g. bevacizumab, VEGF TKI's) is allowed.
  • Platinum refractory is defined as progression during platinum-containing therapy or within 4 weeks of last dose.
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  • Platinum resistant is defined as relapse-free interval 1-6 months of a platinum-containing therapy
  • Prior Therapy: Unlimited prior systemic therapies are allowed.
  • ECOG performance status of 0-1 (Appendix A)
  • Adequate normal organ and marrow function as defined below.
  • Hemoglobin ≥9.0 g/dL.
  • Absolute neutrophil count (ANC) > 1500/mm3.
  • Platelet count ≥100 x 109/L
  • Serum bilirubin ≤1.5 x ULN. This will not apply to patients with confirmed Gilbert's syndrome (persistent or recurrent hyperbilirubinemia that is predominantly unconjugated in the absence of hemolysis or hepatic pathology), who will be allowed only in consultation with their physician.
  • AST (SGOT)/ALT (SGPT) ≤2.5 x ULN unless liver metastases are present, in which case it must be ≤5x ULN.
  • Measured creatinine clearance (CL) >40 mL/min or Calculated creatinine CL>40 mL/min by the Cockcroft-Gault formula (Cockcroft and Gault 1976) or by 24-hour urine collection for determination of creatinine clearance:
  • Creatinine CL (mL/min) = Weight (kg) x (140 - Age) x 0.85 72 x serum creatinine (mg/dL)
  • Evidence of post-menopausal status or negative urine or serum pregnancy test for female pre-menopausal patients. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause. The following age-specific requirements apply:
  • Women <50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of exogenous hormonal treatments and if they have luteinizing hormone and follicle-stimulating hormone levels in the post-menopausal range for the institution or underwent surgical sterilization (bilateral oophorectomy or hysterectomy).
  • Female patients of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential. Acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal. For both male and female patients, effective methods of contraception must be used throughout the study and for three months following the last dose.
  • Women ≥50 years of age would be considered post-menopausal if they have been amenorrheic for 12 months or more following cessation of all exogenous hormonal treatments, had radiation-induced menopause with last menses >1 year ago, had chemotherapy-induced menopause with last menses >1 year ago, or underwent surgical sterilization (bilateral oophorectomy, bilateral salpingectomy, or hysterectomy).
  • Measurable disease by RECIST v1.1

Who cannot join

  • Exclusion criteria will be assessed within 28 days of starting study treatment. Patients meeting any of the following exclusion criteria are not eligible to enroll in this study.
  • Radiation, chemotherapy, or immunotherapy or any other anticancer therapy ≤2 weeks prior to cycle 1 day 1.
  • Use of an anti-cancer treatment drug or investigational drug during the last 28 days or 5 half-lives (whichever is shorter) prior to cycle 1 day 1. A minimum of 10 days between termination of prior treatment and administration of study treatment is required.
  • Patients with known or suspected conditions likely to increase gastrointestinal toxicity, such as inflammatory bowel disease, bowel obstruction, history of bowel obstruction, or overt bowel involvement by tumor.
  • Patients who are pregnant or lactating.
  • Major surgery </= 28 days prior to cycle 1 day 1.
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  • Unstable cardiovascular function:
  • ECG abnormalities requiring treatment, or
  • congestive heart failure (CHF) of NYHA Class ≥3, or
  • myocardial infarction (MI) within 3 months.
  • Uncontrolled infection requiring parenteral antibiotics, antivirals, or antifungals within one week prior to first dose; patients with controlled infection or on prophylactic antibiotics are permitted in the study.
  • Any known history or evidence of hepatitis A, B, or C infection; or known to be positive for HCV RNA or HBsAg (HBV surface antigen); Known to be HIV seropositive
  • Grade >2 peripheral neuropathy at baseline (within 14 days prior to cycle 1 day 1).
  • Serious psychiatric or medical conditions that could interfere with treatment;
  • Participation in an investigational anti-cancer study within 3 weeks prior to Cycle 1 Day 1
  • Concurrent therapy with approved or investigational anticancer therapeutic other than steroids.
  • Patients with coagulation problems and active bleeding within 4 weeks prior to C1D1 (peptic ulcer, epistaxis, spontaneous bleeding)
  • Patients with symptomatic brain lesions
  • Evidence of bleeding diathesis or significant coagulopathy (in the absence of therapeutic anticoagulation).
  • History of hemoptysis (1/2 teaspoon of bright red blood per episode) within 1 month of study enrollment for any tumor type.
  • Non-healing wound, ulcer or bone fracture.
  • Known hypersensitivity to lurbinectedin, paclitaxel, bevacizumab or excipients.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Shannon Westin, MD contact

713-794-4314

swestin@mdanderson.org

United States1 site, 1 recruiting

  • M D Anderson Cancer Center

    Houston, Texas, 77030

    Shannon Westin, MD, 713-794-4314, swestin@mdanderson.org

    Shannon Westin, MD

    Recruiting

Other trials in United States

About this study

To learn if adding lurbinectedin to the combination of paclitaxel and bevacizumab can help to control advanced cancer.

Read the detailed description

Primary Objectives:

  • To identify dose-limiting toxicities (DLTs) and recommended phase 2 dose (RP2D) of the combination of paclitaxel/bevacizumab/lurbinectedin in women with platinum resistant ovarian cancer.
  • To assess macrophage counts by image cytometry in women with platinum resistant ovarian cancer treated with weekly paclitaxel/bevacizumab/lurbinectedin.

Secondary Objectives:

  • To assess objective response (OR) and duration of response (DOR).
  • To assess clinical benefit rate (CBR), defined as proportion of patients with OR or stable disease (SD) > 4 months.
  • To estimate progression free survival (PFS) and overall survival (OS) for at least 12 months

Exploratory Objectives:

--To assess differential effects from baseline, within and between patient treatment cohorts, on macrophage and hypoxia markers, CSF1/R and MHCII, plasma biomarker (VEGF, VEGFR, IL6, IL8, FGF, PDGFAA), tumor and macrophage-derived exosomes, resident macrophage populations in tissue pre-enrollment and after induction bevacizumab (CD11b +CD68, CD11b +CD14/CD15/CD33, CD11b +CD11c, MHCII, CD168+, CD4/CD8, NK, Treg) by multicolor tissue cytometry, as well as serial changes in vivo imaging such as tumor size, macrophage-specific imaging, ADC for cellularity, and DCE for vasculature.

Conditions
Ovarian Cancer
Being tested
Paclitaxel, Bevacizumab, Lurbinectedin
Medical subject headings
Ovarian Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PaclitaxelDrug

    Also called Taxol

    Given by (IV) vein

  • BevacizumabDrug

    Also called Avastin™, Anti-VEGF monoclonal antibody, rhuMAb-VEGF

    Given by (IV) vein

  • LurbinectedinDrug

    Given by (IV) vein

Study groups in NCT05636111
Study groupRoleWhat they receive
Dose Escalation and Dose ExpansionExperimentalPariticipants will be assigned to a dose level of combined paclitaxel, bevacizumab, and lurbinectedin
Receives: Drug: Paclitaxel; Drug: Bevacizumab; Drug: Lurbinectedin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

    Measured: through study completion; an average of 1 year.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Dec 2022
  2. Study start12 Jul 2023
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
34 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05636111
Sponsor's protocol ID
2022-0231
Other IDs
NCI-2022-10037
Status last verified
Aug 2026
First submitted
23 Nov 2022
Last updated
20 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Paclitaxel, Bevacizumab and Lurbinectedin in people with Ovarian Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 22 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 20 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Shannon Westin, MD (713-794-4314, swestin@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 (time frame: through study completion; an average of 1 year.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05636111.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2026.

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